Pradaxa (Dabigatran) and the FDA Safety Review

By Independent Staff Writer
Although only on the market for a relatively short period of time, Pradaxa, the blood-thinning drug manufactured by Boehringer Ingelheim—has already suffered under the weight of threatened recalls, lawsuits and warnings by the FDA. Pradaxa is the first FDA-approved drug of its type since the drug Warfarin was approved in 1954. Both Warfarin and Pradaxa are commonly prescribed as blood thinners to reduce the risk of stroke in patients with heart rhythm irregularities.

The Dangers of Pradaxa (Dabigatran) Part 3 of 3: Serious Vascular Risks

By Independent Staff Writer

Pradaxa, the drug which less than a couple of years ago seemed like a dream come true for the hundreds of thousands of patients who were taking Warfarin or Coumadin has had its initial glow tarnished by the ever-increasing number of reports of serious side effects from use of the drug. Although Warfarin has been used as a stroke inhibitor and for those suffering from atrial fibrillation since the 1950’s, it comes with certain restrictions and its own set of side effects. Those who are on a Warfarin regimen must have regular blood tests taken, and must also be very careful of foods and other prescription drugs they mix with Warfarin.

However, there is a significant difference in the way Warfarin and Pradaxa work in the body, most notably the fact that in the event Warfarin causes excessive bleeding, the effects can be reversed by administering a dose of Vitamin K. When Pradaxa causes excessive bleeding there is no known antidote, leaving the patient vulnerable to literally bleeding to death. Pradaxa is a direct thrombin inhibitor which, in the initial 18,000 person trial, showed great promise in reducing strokes and helping those patients with atrial fibrillation lead a healthier life. The manufacturer of the drug, Boehringer Ingelheim, has been accused of rushing through the initial trial in order to get their drug on the market before other potential rivals, ignoring some potential risks in the process.